Senior Medical – Regulatory Writer at Syneos Health

Remote
Syneos Health

Senior Medical (Regulatory) Writer – (19007926)

JOB SUMMARY

Serves as a senior medical writer on clinical study or regulatory project teams. Writes, edits, and coordinates content for clinical/regulatory while serving as primary technical contact with the internal team and the client.

JOB RESPONSIBILITIES

  • Mentors and leads less experienced medical writers on complex projects, as necessary.
  • Acts as lead for assigned writing projects.
  • Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision.
  • Develops or supports a variety of documents that include, but not limited to:
    • Clinical study protocols and clinical protocol amendments;
    • Clinical study reports;
    • Patient narratives;
    • Clinical development plans;
    • IND submissions and annual reports;
    • Integrated summary reports;
    • NDA and (e)CTD submissions;
    • Investigator brochures, as well as;
    • Clinical journal manuscripts, clinical journal abstracts, and client presentations.
  • Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.
  • Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.
  • Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.
  • Serves as peer reviewer on internal review team providing review comments on draft and final documents
  • Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget
  • Performs on-line clinical literature searches, as applicable.
  • Maintains familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing
  • Maintains awareness of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership.

REQUIREMENTS:

  • Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise.
  • Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide.
  • Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills and ensure a team-oriented approach.
  • Strong proficiency in Word, Excel, PowerPoint, email, and Internet.
  • Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information.

Primary Location North America – US Home-Based

Job Medical Affairs

Schedule Full-time

Travel No

Employee Status Regular

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